Continuous Glucose Monitoring in Adolescents With Poorly Controlled Type 1 Diabetes

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2014-06-30

Brief Summary

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The purpose of this study is to see if children and adolescents with poorly controlled type 1 diabetes will benefit from using a continuous glucose monitor (CGM), a device that can be used to check blood sugars.

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Detailed Description

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Adolescents with type 1 diabetes, HbA1c ≥9% on insulin pumps were admitted to the clinical research center and a continuous glucose sensor was inserted. Sensor glucose (SG) values were compared to plasma glucose measured at least hourly using Yellow Springs Instrument's (YSI) glucose analyzer. SG rather than YSI was used for treatment decisions unless YSI was \<70 mg/dL or specific criteria indicating SG and YSI were very discordant were met.

Conditions

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Type 1 Diabetes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CGM in adolescents with poorly-controlled T1D

Adolescents with poorly controlled type 1 diabetes on insulin pumps were admitted to the clinical research center (CRC) and a continuous glucose sensor was inserted. Sensor glucose (SG) values were compared to plasma glucose measured at least hourly using Yellow Springs Instrument's (YSI) glucose analyzer. SG rather than YSI was used for treatment decisions unless YSI was \<70 mg/dL or specific criteria indicating SG and YSI were very discordant were met.

Group Type EXPERIMENTAL

Continuous Glucose Monitor (CGM)

Intervention Type DEVICE

CGM during 24-hr CRC stay.

Interventions

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Continuous Glucose Monitor (CGM)

CGM during 24-hr CRC stay.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 12 to \<18 years old
* T1D for at least one year
* Treatment with insulin pump therapy
* A1c ≥9%
* Willingness to comply with study procedures

Exclusion Criteria

* Current diabetic ketoacidosis
* Hypoglycemia unawareness
* Chronic use of medications that affect recognition of hypoglycemia (e.g., beta blockers)
* Chronic use of medications that mimic symptoms of high or low blood sugars (e.g., decongestants)
* Recent or frequent severe hypoglycemia (2 episodes in the last year; 1 episode in the last 6 months)
* Skin rashes or conditions that may affect CGM placement and wear

Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No